EP2382923B1 - Druck-/Vakuumbetriebene Biopsievorrichtung - Google Patents

Druck-/Vakuumbetriebene Biopsievorrichtung Download PDF

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Publication number
EP2382923B1
EP2382923B1 EP11305507.3A EP11305507A EP2382923B1 EP 2382923 B1 EP2382923 B1 EP 2382923B1 EP 11305507 A EP11305507 A EP 11305507A EP 2382923 B1 EP2382923 B1 EP 2382923B1
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EP
European Patent Office
Prior art keywords
catheter
forceps
fluid
lumen
vacuum
Prior art date
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Not-in-force
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EP11305507.3A
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English (en)
French (fr)
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EP2382923A1 (de
Inventor
Erhan H. Gunday
Lawrence J. Gerrans
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Sanovas Inc
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Sanovas Inc
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Publication of EP2382923A1 publication Critical patent/EP2382923A1/de
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet

Definitions

  • the invention relates to the field of medical diagnosis and treatment. More specifically, the invention relates to catheter forceps that are actuated by pressurized fluid and/or vacuum, and are adapted for tissue sampling and withdrawal for examination and analysis.
  • Biopsy is a commonly performed medical procedure in which tissue samples are obtained for diagnostic purposes. Such a procedure typically includes cutting a tissue sample and then retrieving the sample from a patient's body.
  • biopsy forceps and devices Numerous types of biopsy forceps and devices have been developed for in vivo medical diagnosis and treatment of different conditions. Such devices are designed for sampling tissue within the body, such as may be performed, for example, in endoscopic, bronchoscopic, laparoscopic, vascular, neurologic and various other types of procedures, to retrieve biopsy samples for analysis and identification of tissue types.
  • the biopsy forceps and devices typically include small diameter swabbing sponges, coring needles and instruments with cutting jaws at a distal end that are operated remotely through an actuator positioned at a proximal end.
  • the biopsy forceps and devices are typically carried on a distal end of an instrument, stick, syringe or catheter, and are positioned around a tissue portion selected for removal and diagnosis.
  • a physician first inserts a catheter portion into a portion of the patient's body from which the tissue sample needs to be taken. The physician then guides the catheter through a passageway, such as a blood vessel, until the biopsy instrument of choice is positioned by a tissue sample site. Next, the physician swabs the surface of the site, inserts the needle into the site and removes a core sample from the site. Alternatively, the physician opens the jaws of the forceps, positions the jaws around the tissue to be sampled, and manipulates the actuator so that the jaws close around the tissue. A sample of the tissue is cut from the biopsy site while it is trapped between the jaws or picked up by other means. Keeping the jaws closed, the physician withdraws the biopsy forceps and opens the jaws to collect the tissue sample.
  • a passageway such as a blood vessel
  • U.S. Patent No. 3,590,808 to Muller describes a biopsy tool that includes a rigid tip for collection of a tissue sample attached to a flexible tube, such as a catheter.
  • the rigid tip includes a knife for cutting off the tissue samples.
  • the advanced forward to cut off the tissue sample by supplying air under positive pressure from a syringe via a first duct, and is then retracted by supplying air under negative pressure from the syringe.
  • the tool also includes a radial cavity for capturing the severed tissue. Vacuum is supplied to the radial cavity through a separate duct to draw the tissue sample into the cavity.
  • US 2008/0300506 A1 discloses a tissue sampling device comprising an elongated tube having a distal end with two apertures. Two cutters are displaced across apertures to sever tissues by mean of a compressed fluid.
  • U.S. Patent No. 3,289,669 discloses a biopsy apparatus having a biopsy capsule for retaining a tissue sample, a syringe coupled to the capsule and a bottle containing saline coupled to the syringe.
  • the capsule has a port with a cutting edge and a telescoping blade member positioned opposite the cutting edge.
  • the device further includes a spring means which urges the blade member and the cutting edge away from each other to maintain the capsule in an opened position.
  • a plunger of the syringe is withdrawn to create vacuum in the capsule, which draws the tissue into the capsule and overcomes for force of the spring to urge the blade member across the port to sever the tissue.
  • U.S. Patent No. 5,335,671 discloses a tissue removal assembly including a movable cutting device disposed inside a cannula, which is connected to a conduit piece for operation of the device by a surgeon.
  • the cannula has a notch adjacent its distal end for capturing a tissue sample that is cut off by moving the cutting device across the notch opening.
  • the known biopsy tools suffer from a number of disadvantages and shortcomings.
  • the prior art biopsy forceps and devices are typically limited to taking a single tissue sample, after which the device may be withdrawn from the patient's body and the tissue collected before the device can be used again to take a second tissue sample. Accordingly, it is a major disadvantage of the existing art to take sufficient sample quantities in an expeditious manner.
  • An additional disadvantage of prior art devices is that it is often very difficult to accurately position the forceps next to the tissue to be sampled.
  • Yet another disadvantage of prior art devices is that the samples are not immediately captured and securely held in a container at the sample site.
  • a forceps device that is capable to taking multiple tissue samples while in the patient's body without the need of withdrawing the device and removing the collected tissue sample before another sample can be collected.
  • a forceps device that can be precisely positioned and actuated to sample indirect tissues, such as those positioned beyond the walls of an airway, lumen or vessel.
  • a repetitively actuated forceps device that can be precisely operated, such that its insertion, actuation, depth and repetition cycles are be known and controlled.
  • a forceps device that is capable of immediately capturing and securely holding a tissue sample in a container at the sample site.
  • a forceps device that can be placed and actuated under direct and/or indirect visualization.
  • An exemplary embodiment of such capability is to facilitate a transbronchial sampling of a lymph node tissue.
  • the catheter has a lumen in fluid communication with both the actuation mechanism and the sampling chamber for providing at least one of a fluid and a vacuum to the actuation mechanism and the sampling chamber.
  • the cutting device has an actuator
  • the step of cutting into tissue comprises providing a vacuum to the actuator to position the cutting device in an activated position, in which the cutting device extends beyond the distal end of the catheter
  • the method further comprises the step of positioning the cutting device in an inactivated position, in which the cutting device does not extend beyond the distal end of the catheter, by supplying a fluid to the actuator.
  • the at least one of a fluid and a vacuum is provided to the actuator of the cutting device via a lumen in fluid communication with the actuator, the actuation mechanism and the sampling chamber.
  • Catheter forceps for extracting a tissue sample including a catheter, a sampling chamber positioned at a distal end of the catheter and having a movable cover, and an actuation mechanism for moving the movable cover to an opened position by providing a fluid to the actuation mechanism and to a closed position by providing a vacuum to the actuation mechanism.
  • the catheter has a lumen in fluid communication with both the actuation mechanism and the sampling chamber for providing at least one of a fluid and a vacuum to the actuation mechanism and the sampling chamber.
  • the lumen supplies a vacuum to the sampling chamber to draw tissue sample into said sampling chamber.
  • the actuation mechanism has a piston positioned in an actuation chamber, and the actuation chamber is in fluid communication with the lumen.
  • fluid is supplied by a fluid source in fluid communication with the lumen.
  • the fluid source further includes a vacuum source.
  • the fluid source is an electro-pneumatic pump.
  • the fluid is a gas.
  • the catheter forceps further includes at least one inflatable balloon positioned on an outer wall of the catheter opposite the sampling chamber.
  • the catheter has a first lumen in fluid communication with both the actuation mechanism and the sampling chamber, and a second lumen in fluid communication with the at least one inflatable balloon for supplying fluid thereto.
  • the catheter forceps further includes a movable cutting device positioned at the distal end of the catheter.
  • the cutting device has an actuator for moving the cutting device to an active position, in which the cutting device extends beyond the distal end of the catheter, and to an inactive position, in which the cutting device does not extend beyond the distal end of the catheter, by providing at least one of a fluid and a vacuum.
  • the catheter has a lumen in fluid communication with the actuation mechanism, the sampling chamber, and the actuator of the cutting device. In other of the above embodiments, the catheter has a first lumen in fluid communication with both the actuation mechanism and the sampling chamber, and a second lumen in fluid communication with the actuator of the cutting device.
  • the catheter and the forceps include direct and/or indirect markings to enable direct and/or indirect visualization of the device.
  • the catheter forceps is controlled by an apparatus that monitors and precisely controls various aspects of the forceps' operation, such as its insertion depth, actuation and cycles of repetition.
  • the catheter forceps is navigated via direct and/or indirect visualization methods to facilitate sampling of indirect tissues, such as a transbronchial sampling of a lymph node tissue.
  • the biopsy forceps is deployed under bronchoscopic visualization in concert with fluoroscopic or ultrasound localization to facilitate the transbronchial biopsy of a specific lymph node.
  • the pressure/vacuum actuated catheter forceps of the present invention may be used with various catheter devices, as well as various types of flexible and rigid endoscopes that include suitable working channels to quickly and efficiently obtain tissue samples from inside the body for pathological examination. If desired, the pressure/vacuum actuated catheter forceps can be made as a single use disposable unit provided in a sterile package at a very low cost.
  • the catheter forceps are used with a steerable catheter system described in U.S. Patent Application No. 13/037,874 .
  • the pressure/vacuum actuated catheter forceps can also be used with conventional instruments such as endoscopes that have suitable working channels.
  • the catheter forceps (10) include a catheter (11) with a distal tip (12). A proximal end of the catheter (11) is connected to a control device, such as a hand piece, described in more detail below.
  • the catheter (11) is preferably made of any suitable material that is sufficiently flexible to facilitate introduction of the catheter forceps (10) into the patient's body through the working channels of the endoscopes or guiding catheters.
  • the catheter can have any suitable length, depending on the particular application for which the forceps are being used.
  • the outer diameter of the catheter (11) should usually be made as small as possible.
  • the catheter (11) can be pre-formed into many different shapes and can be used with various additional devices.
  • the catheter (11) may be coupled with an imaging system, e.g. a fiber optic image bundle, for imaging of the surrounding area during the introduction of the catheter forceps (10) into the patient's body.
  • an imaging system e.g. a fiber optic image bundle
  • Two separate bundles, one for illumination and the other for imaging can also be used.
  • other sources of illumination and/or imaging may also be employed.
  • the image sensor and/or illumination source can be located at the tip of the catheter forceps (10), eliminating the need for a coherent imaging fiber bundle, thus increasing image quality and reducing cost.
  • the catheter (11) includes imaging markers, such as radio opaque rings, located throughout the length of, or at or near, the distal tip (12).
  • imaging markers such as radio opaque rings, located throughout the length of, or at or near, the distal tip (12).
  • imaging markers can be selected and appropriately positioned in order to reflect the relevant waves of various imaging modalities (e.g., x-ray) in order to allow the use of such modalities to assist with the precise positioning of the catheter forceps (10) inside a bodily cavity, as further discussed below.
  • the distal tip (12) is made out of a material suitable for medical applications, such as plastic or metal.
  • a material suitable for medical applications such as plastic or metal.
  • a range of polymers can be used for the construction of the distal tip, such silicone rubber, latex, or thermoplastic elastomers.
  • any suitable type of a metal, such as stainless steel, may be used.
  • the distal tip (12) of the catheter forceps (10) may come in a variety of sizes and diameters, which can be selected to suit the particular application for which the forceps are being used. This variety of available distal tip sizes allows the catheter forceps to be used in bodily cavities of various diameters and dimensions, such as large and small bronchial branches, sinuses, and vessels, having different types of tissues to be sampled.
  • the outer diameter of the distal tip (12) may be 1 mm or less.
  • the distal tip (12) of the catheter forceps (10) may also come in a variety of shapes.
  • the distal tip (12) has a rounded shape adapted to provide an easy passage through the working channel(s) of the various guiding catheters and/or endoscopes used to deploy the forceps (10).
  • the distal tip (12) can also include an access opening, through which a cutting device can be extended when the forceps (10) are actuated, such that the forceps can easily cut into the tissue from which a tissue sample is to be obtained.
  • a cutting device such as, for example, a sharp edge knife, may be used, depending on a type of the tissue to be sampled. The structure and operation of the cutting device is further described below.
  • the catheter forceps (10) further include a sampling chamber (14) positioned at the distal end of the forceps (10) for capturing and retaining a tissue sample.
  • the sampling chamber (14) includes a movable cover (16), which is adapted to be opened and closed, capturing the tissue sample within the sampling chamber (14).
  • the sampling chamber (14) typically remains closed during deployment of the forceps (10) through a working channel of a guiding catheter or an endoscope until it reaches the target tissue.
  • the sampling chamber (14) can have any suitable shape and size depending on a particular application. It is desirable that the shape of the cover (16) is such that the volume of sampling chamber (14) is maximized for capturing larger tissue samples.
  • the distal end of the movable cover (16) preferably includes a sharpened edge (18) that functions as a cutting device for resecting the tissue sample.
  • a distal end of the sampling chamber (14) also preferably has a sharpened edge (20) corresponding to the sharpened edge (18) of the movable cover (16) such that the tissue sample is resected by both sharp edges (18) and (20) as the movable cover (16) is moving to a closed position. This way, when the movable cover (16) is moving forward, it is closing the specimen chamber (14) while simultaneously cutting the tissue and capturing the tissue sample within the chamber.
  • the tissue to be sampled is removed by a device other than the catheter forceps (10), such as a resecting surface molded in or affixed to a balloon of a resector balloon system, as is described in U.S. Patent Application No. 12/269,495 , .
  • the distal edge of the chamber (14) may include a fixedly positioned sharp edge knife (not shown) that aids in cutting of the tissue to be sampled. When the sampling chamber (14) is closed, the sharp edge knife is not exposed, so that the catheter forceps (10) may be safely introduced into the patient's body.
  • the cover (16) moves forward and backward when it is activated with pressurized fluid (e.g., air) and/or vacuum.
  • pressurized fluid e.g., air
  • the catheter (11) can have a very small diameter, which facilitates the introduction of the shaft into a body cavity.
  • the movable cover (16) is connected to an actuation mechanism for moving the movable cover between opened and closed positions.
  • the actuation mechanism includes a rod (22) connected to a piston (24).
  • the piston (24) is slidably disposed in an actuation chamber (26), as illustrated in FIG. 3 .
  • the actuation chamber is in fluid communication with a lumen (28) provided in the catheter (11).
  • the lumen (28) is used to provide a fluid and a vacuum to the actuation mechanism to actuate the movable cover (16).
  • the lumen (28) is also in fluid communication with the sampling chamber (14) via a lumen (30).
  • the lumen (30) has a plurality of holes (32) through which a vacuum is provided to the sampling chamber (14) via the lumen (28).
  • the actuation mechanism is retained inside the catheter by a holder (34), which also functions to separate the sampling chamber (14) from the lumen (28).
  • FIGS. 5A-5D illustrate a stepwise actuation of the catheter forceps during the biopsy procedure.
  • the catheter forceps (10) are primed with the sampling chamber cover (16) in the closed position.
  • the catheter forceps are introduced into a bodily cavity via a suitable catheter or endoscope device and are positioned next to the target tissue (36) to be sampled, as shown in FIG. 5A .
  • a pressurized fluid is supplied to the lumen (28) of the catheter (11) via a fluid source.
  • the pressurized fluid enters the actuation chamber (26) and causes the piston (24) together with the attached rod (22) to move toward the proximal end of the catheter (11), as illustrated in FIG. 5B .
  • This causes the movable cover (16) to open.
  • the supply of pressurized fluid is terminated and a vacuum is provided to the lumen (28) from the fluid source, as shown in FIGS. 5C-D .
  • the vacuum is established in the sampling chamber (14) via the lumen (30) and through the plurality of openings (32).
  • the established vacuum in the sampling chamber (14) draws the tissue sample (38) into the chamber and aids in retention of the tissue sample inside the chamber (14).
  • the vacuum is provided to the actuation chamber (26) via the lumen (28), which causes the piston (24) with the attached rod (22) to move toward the distal end of the catheter (11).
  • the catheter forceps (10) may be withdrawn from the patient's body through the same catheter/endoscope lumen. After the catheter forceps (10) are withdrawn, the pressurized fluid is again supplied to the actuation mechanism via the lumen (28) to open the cover (16) and to retrieve the tissue sample (38) from the sampling chamber (14) for analysis.
  • the catheter forceps of the present invention may include various cutting devices to assist in positioning the forceps adjacent to the target tissue.
  • the catheter forceps (50) includes a cutting device (58) positioned at the distal end (52) of the forceps and slidably attached to the catheter (51).
  • the cutting device is extended into an activated position, in which the cutting device (60) extends beyond the distal end (52) of the catheter (51) through an opening (60) provided at the distal end of the catheter, as shown in FIG. 6 .
  • the cutting device (58) can be made with any suitable material and can have any suitable shape. In the embodiment shown in FIG. 6 , the cutting device (58) has a triangular shape with a sharp side edges that facilitate cutting into the surrounding tissue.
  • the cutting device (58) is actuated by an actuation mechanism comprising an actuation chamber (62) and a piston (64) slidably arranged inside the chamber (62) and coupled to the cutting device (58).
  • the cutting device is actuated by providing at least one of a fluid and a vacuum to the actuation chamber (62) via a lumen (66) fluidly connected to the fluid source, such as a pump.
  • the lumen (66) is fluidly isolated from the lumen (28) that supplies fluid/vacuum to the sampling chamber (54) and to the actuation mechanism (55) that actuates the movable cover (56).
  • fluid/vacuum can be supplied to the cutting device (58), the sampling chamber (54) and the movable cover (56) via the same lumen in the catheter (51). This can be accomplished, for example, by extending lumen (30) to a portion of the actuation chamber (62), either proximal or distal of the piston (64), as appropriate.
  • the cutting device (58) is positioned into the inactivated position, in which the cutting device (58) does not extend beyond the distal end of the catheter (51), as illustrated in FIG. 7A .
  • This is achieved by providing vacuum from the fluid source to the actuation chamber (62) via the lumen (66) to pull the piston (64) toward the proximal end of the catheter, which in turn brings the cutting device (58) inside the catheter housing.
  • vacuum can be applied to move the cutting device (58) into an activated position, and pressurized fluid can be supplied to move the cutting device (58) into an inactivated position.
  • the catheter forceps of the present invention further includes an inflatable device to facilitate positioning of the forceps in larger bodily cavities, such as lung passageways.
  • the catheter (51) includes an inflatable balloon (68) positioned on the outer wall of the catheter.
  • the inflatable balloon (68) is positioned opposite the sampling chamber cover (56).
  • the inflatable balloon (68) can be positioned at any other suitable location along the catheter.
  • a plurality of inflatable balloons can be positioned at different locations along the catheter (51) to further facilitate maneuvering and positioning of the catheter forceps inside a bodily cavity.
  • the inflatable balloon(s) can also be used as a tamponade to control and/or stop bleeding from the tissue. The bleeding is tamponaded by inflating the inflatable balloon to create compression.
  • the inflatable balloon is inflated by supplying fluid thereto from the fluid source via a lumen (70).
  • the lumen (70) is separate from the lumens (28) and (66) that are used to supply fluid/vacuum to the sampling chamber (54), the movable cover (56) and the cutting device (58).
  • the fluid can be supplied to the inflatable balloon (68), the sampling chamber (54), the cover (56) and/or the cutting device (58) via a single lumen.
  • vacuum is provided to the balloon via the lumen (70) from the fluid source.
  • the cutting devices used with the catheter forceps of the present invention can have various shapes and functions.
  • the cutting device (76) has an anchor-like shape, with a sharpened distal end (78) and four paddles (79).
  • the cutting device (76) is coupled to an actuation mechanism (84), such as a piston, which in turn is fluidly connected to a fluid/vacuum source.
  • the cutting device (76) is actuated by supplying at least one of fluid and vacuum to the actuation mechanism (84) to position the cutting device (76) into an active position, as shown in phantom lines in FIG. 8 .
  • the catheter forceps (75) is pushed into the tissue to be sampled, such that the sharpened distal end (78) of the cutting device (76) cuts into the tissue.
  • the cutting device is retracted back into the forceps housing by supplying at least one of fluid and vacuum to the actuation mechanism (84).
  • the paddles (79) scoop the tissue sample and draw is back into the sampling chamber (77) provided at the distal end of the catheter.
  • the sampling chamber (77) typically includes a lumen (73), which fluidly couples the chamber (77) with a fluid source.
  • the movable cover provided on the side of the sampling chamber may be eliminated such that the tissue sample is drawn into the sampling chamber (77) only from the distal end of the catheter. Such embodiment is not covered by the invention.
  • the sampling chamber cover (81) has a cylindrical shape with a sharpened edge (83) extending along the longitudinal axis of the cover.
  • the cover is coupled to an actuation mechanism, such as a rod (82).
  • actuation mechanism such as a rod (82)
  • the cylindrical cover (81) is rotated around its longitudinal axis, shown by an arrow in FIG. 10 , via the rod (82) such that the tissue sample is cut off and captured inside the sampling chamber.
  • the cover (81) is actuated manually by rotating the rod (82) embodiment not covered by the invention) or pneumatically by supplying fluid and/or vacuum to any suitable pneumatic mechanism.
  • the sampling chamber cover with the cutting device can also be provided at the distal end of the catheter forceps, as shown in FIG. 10 .
  • the cover (86) includes a number of segments, in this case three, that join together to make a sharpened tip when in a closed position shown in this figure.
  • the catheter forceps (85) is introduced into the bodily cavity and placed adjacent to the target tissue, the cover (86) is moved into an opened position (not shown) by an actuation mechanism (87) coupled to each of the cover sections (86).
  • the actuation mechanism (87) is a piston positioned proximally to the sampling chamber (89).
  • Each of the cover sections (86) is coupled to the piston (87) via a connector (88), such as a rod.
  • the actuation mechanism (87) is actuated by supplying at least one of fluid and vacuum thereto from a fluid/vacuum source.
  • the sections of the cover (86) open, or move outward from the center axis, forming a passage into the sampling chamber (89) provided at the distal end of the catheter forceps (85).
  • a lumen (95) may be provided to supply vacuum to the sampling chamber (89) from the fluid/vacuum source to further draw the tissue sample into the chamber (89).
  • the catheter forceps (90) include a half spherical cover (91) for the sampling chamber.
  • the cover (91) has a sharpened knife-like edge (92) and turns about its center axis (93), as shown in FIG. 11 .
  • the cover (91) is opened by applying pressure to the actuation mechanism (not shown), and is closed when a vacuum is supplied.
  • the cover (91) closes, the supplied vacuum pulls the tissue sample into a half sphere space (94) of the spherical cover (91) and into the sampling chamber, as the tissue is being cut by the sharpened edge (92) of the cover (91).
  • the half-spherical cover (91) is opened and closed by interchangeably supplying pressure and vacuum, tissue samples are cut off into the half sphere chamber (94) and suctioned into the sampling chamber.
  • FIGS. 12A and 12B illustrate the use of the catheter forceps (50) with the inflatable balloon (68) inside a bodily cavity (72).
  • the catheter forceps (50) is introduced into the patient's bodily cavity (72) and positioned adjacent to the target tissue (74), as shown in FIG. 12A .
  • the inflatable balloon (68) is inflated by supplying fluid thereto, such that it pushes the catheter (51) against the bodily cavity wall, thus positioning the catheter closer to the tissue (74) to be sampled, as shown in FIG. 12B .
  • the sampling chamber cover is opened, and the tissue sample is resected and captured inside the sampling chamber by closing the chamber cover.
  • the balloon (68) can then be rotated such that it is pressed against the resected tissue (74) to control the bleeding. Then, the balloon (68) is deflated by providing vacuum thereto and the catheter forceps (50) are withdrawn from the bodily cavity.
  • the catheter forceps of the present invention can be precisely positioned and actuated to sample indirect tissues, such as those positioned beyond the walls of an airway, lumen or vessel.
  • the placement and actuation of the catheter forceps can be carried out under direct and/or indirect visualization.
  • FIG. 13 illustrates actuation of the catheter forceps (50) under indirect visualization for sampling a tissue sample (74) located beyond the walls of a bodily cavity (72).
  • This procedure is particularly suited for performing a transbronchial sampling of a lymph node tissue.
  • the catheter forceps (50) is introduced into the bodily cavity (72) and guided toward the target tissue (74) positioned outside of the bodily cavity wall.
  • the positioning of the catheter forceps (50) is monitored and visualized externally via an imaging modality (96), such as an ultrasound or x-ray device.
  • the distal tip of the catheter forceps (50) includes imaging markers, e.g.
  • the cutting device (97) disposed at the distal end of the forceps (50) is actuated to cut through the bodily cavity wall and into the tissue (74).
  • the positioning of the catheter forceps inside a bodily cavity can also be visualized internally, as shown in FIG. 14 .
  • the forceps (50) is introduced into the bodily cavity (72) via a lumen in an endoscope (98).
  • the endoscope (98) includes an imaging modality (99), e.g. an ultrasound device, positioned at the distal end of the endoscope (98).
  • the imaging modality (99) emits waves, such as ultrasound waves, that reflect from the tissue (74) and the imaging markers provided on the forceps (50), as shown in FIG. 14 , such that the precise positioning and operation of the forceps can be visualized and monitored.
  • other suitable internal and external imaging modalities can be used in accordance with the present invention.
  • both the internal and external imaging modalities can be used to facilitate the positioning and actuation of the catheter forceps of the present invention.
  • a vacuum source such as a Festo model VN-05-L-T3-PQ2-VQ2-R01-B, may also be included in the pump so that negative pressure can be applied to the lumens (28, 66, 70).
  • the vacuum source may be turned on and off by a microcontroller via an electrical output signal.
  • a front panel of the pump includes an interface for a control device, such as a hand piece, further described below.
  • the control device can be hardwired or wirelessly connected to the pump using readily available communication technologies, such as infrared or radio frequency (e.g., Bluetooth).
  • a proximal end of the catheter forceps typically includes a control device, such as a hand piece, for actuation of the forceps by a physician.
  • a control device such as a hand piece
  • An exemplary embodiment of the hand piece (100) is illustrated in FIG. 15 .
  • the hand piece (100) includes a connector (102) for connection to the proximal end of the catheter forceps and another connector (120) for connection to a fluid source, such as a pump. Any suitable type of connector can be used in accordance with the present invention.
  • the hand piece (100) further includes a plurality of control buttons (110).
  • the hand piece (100) includes an "open” button that is used to supply fluid to the catheter forceps to open the movable cover of the sampling chamber, and a “cut” button that is used to provide vacuum to the forceps to close the cover and to cut the sample tissue.
  • Additional buttons, such as “extend” and “retract” buttons shown in FIG. 15 can be included on the hand piece (100) to actuate the cutting device positioned at the distal end of the forceps.
  • buttons labeled as “inflate” and “deflate” are used to inflate and deflate the inflatable balloon provided on the catheter forceps.
  • the fluid and/or vacuum are supplied to the lumens (28, 66, 70) of the catheter forceps shown in FIG. 7A from a pump.
  • the lumens (28, 66, 70) may be coupled to pressure ports (not shown), which control the flow of fluid from the fluid source to the lumens (28, 66, 70).
  • the hand piece (100) may include valves and valve control devices/electronics known in the art.
  • microprocessor-controlled solenoid valves may be used to control the fluid flow and vacuum.
  • fluid pressure may be continuously monitored by a microcontroller using pressure regulators at the input from a tank, output of the regulator, and output to the lumens (66, 68, 70).
  • Appropriate pressure regulators such as, for example, Festo model SDET-22T-D10-G14-U-M12, provide to the microcontroller analog electrical signal (0V-10V) inputs that vary proportionally to the pressure at the regulators.
  • the gas may pass through an electronic flow meter, such as a Festo model SFET-F010-L-WQ6-B-K1, and a filter, before being delivered to the lumens (66, 68, 70) the catheter forceps.
  • the hand piece (100) further includes a holding area (125) for gripping by the physician.
  • the holding area is ergonomically shaped to facilitate comfortable gripping.
  • the hand piece can have any suitable configuration, and that the above configuration is not necessary for achieving the objects of the invention. It is further noted that, in some embodiments, some or all of the actuation commands can be executed via voice control instead of the buttons.
  • the catheter forceps of the present invention are advantageous over known prior art devices in that the forceps are miniaturized, low cost and disposable, intended to be deployed through working channels of various endoscopes and/or steerable catheters.
  • the catheter forceps of the present invention are capable of obtaining biopsy tissue samples from the far reaches of the bodily lumens.
  • the forceps parts can be advantageously made of molded plastic, such that the distal tip of the catheter forceps may be removed from the rest of the catheter to be sent for testing and subsequently discarded after the tissue sample is retrieved from the sampling chamber.
  • the forceps part can be detached from the catheter portion via any suitable means, such as by unscrewing it, twisting it off, snapping it off, or simply cutting it off at a point after the rigid portion.

Claims (14)

  1. Katheterpinzette (10) zum Extrahieren einer Gewebeprobe, mit:
    einem Katheter (11);
    einer Probenkammer (14), die an einem distalen Ende des Katheters (11) positioniert ist und eine bewegliche Abdeckung (16) aufweist; und
    einem Betätigungsmechanismus (22, 24) zum Betätigen der beweglichen Abdeckung (16),
    dadurch gekennzeichnet, dass die bewegliche Abdeckung (16) als Reaktion auf eine Zufuhr eines Fluides innerhalb einer Betätigungskammer (26) des Betätigungsmechanismus (22, 24) in eine geöffnete Position bewegt wird, wobei die Betätigungskammer (26) sowohl ein Vakuum an die Probenkammer (14) liefert, um eine Gewebeprobe in die Kammer zu ziehen, als auch den Betätigungsmechanismus (22, 24) bewegt, um die bewegliche Abdeckung (16) als Reaktion auf eine Zufuhr eines Vakuums innerhalb der Betätigungskammer (26) zu schließen.
  2. Katheterpinzette (10) nach Anspruch 1, bei der der Katheter (11) einen Hohlraum (28) in fluidmäßiger Verbindung mit sowohl dem Betätigungsmechanismus (22, 24) als auch der Probenkammer (14) aufweist, um wenigstens eines von einem Fluid und einem Vakuum für den Betätigungsmechanismus und die Probenkammer bereitzustellen.
  3. Katheterpinzette (10) nach Anspruch 2, bei der der Hohlraum (28) das Vakuum an die Probenkammer (14) bereitstellt, um die Gewebeprobe in die Probenkammer zu ziehen.
  4. Katheterpinzette (10) nach Anspruch 2, bei der der Betätigungsmechanismus einen Kolben (24) aufweist, der in einer Betätigungskammer (26) positioniert ist, und wobei die Betätigungskammer (26) in fluidmäßiger Verbindung mit dem Hohlraum (28) ist.
  5. Katheterpinzette (10) nach Anspruch 2, bei das Fluid von einer Fluidquelle in fluidmäßiger Verbindung mit dem Hohlraum (28) bereitgestellt wird.
  6. Katheterpinzette (10) nach Anspruch 5, bei der die Fluidquelle ferner eine Vakuumquelle umfasst.
  7. Katheterpinzette (10) nach Anspruch 5, bei der die Fluidquelle eine elektropneumatische Pumpe ist.
  8. Katheterpinzette (10) nach Anspruch 1, bei der das Fluid ein Gas ist.
  9. Katheterpinzette (50) nach Anspruch 1, die ferner wenigstens einen aufblasbaren Ballon (68) aufweist, der an einer Außenwand des Katheters (51) gegenüber der Probenkammer (54) angeordnet ist.
  10. Katheterpinzette (50) nach Anspruch 9, bei der der Katheter (51) einen Hohlraum (28) in fluidmäßiger Verbindung sowohl mit dem Betätigungsmechanismus als auch der Probenkammer (54) und mit einem zweiten Hohlraum (70) in fluidmäßiger Verbindung mit dem wenigstens einen aufblasbaren Ballon (68) aufweist, um diesem Fluid zuzuführen.
  11. Katheterpinzette (50) nach Anspruch 1, die ferner eine bewegliche Schneideinrichtung (58) aufweist, die an einem distalen Ende des Katheters (51) angeordnet ist.
  12. Katheterpinzette (50) nach Anspruch 11, bei der die Schneideinrichtung (58) einen Aktuator (64) aufweist, um die Schneideinrichtung (58) in eine aktive Position zu bewegen, in der die Schneideinrichtung (58) über das distale Ende (51) des Katheters hinaus hervorsteht, und in eine inaktive Position zu bewegen, in der die Schneideinrichtung (58) nicht gegenüber dem distalen Ende des Katheters (51) hervorsteht, indem wenigstens eines von einem Fluid und einem Vakuum zugeführt wird.
  13. Katheterpinzette (50) nach Anspruch 12, bei der der Katheter (51) einen Hohlraum in fluidmäßiger Verbindung mit dem Betätigungsmechanismus (22, 24), der Probenkammer (14) und dem Aktuator (64) der Schneideinrichtung (58) aufweist.
  14. Katheterpinzette (50) nach Anspruch 12, bei der der Katheter (51) einen ersten Hohlraum (28) in fluidmäßiger Verbindung mit sowohl dem Betätigungsmechanismus (22, 24) als auch mit der Probenkammer (14) und mit einem zweiten Hohlraum (66) in fluidmäßiger Verbindung mit dem Aktuator (64) der Schneideinrichtung (58) aufweist.
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US9241692B2 (en) 2016-01-26
EP2382923A1 (de) 2011-11-02

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